The prior art is replete with surgical suturing devices, including surgical needle holders, devices which force a surgical needle through tissue and instruments which grasp and stabilize tissue to be sutured between opposed jaws. Surgical instruments also are known in the art which provide adequate control over both the suturing needle and the tissue to be sutured. For instance, in the field of open surgery, surgical tools which both grasp thick tissue and force the needle therethrough are known, as represented by U.S. Pat. No. 2,213,830 to Anastasi and U.S. Pat. No. 1,933,024 to Nagelmann. These devices comprise scissor-like arms which expand laterally when opened. Although appropriate for use in open surgery, such devices are unsuitable for use in non-open surgery since they cannot be introduced through a tubular conduit and their bulky design cannot be modified to conform with the restricted operating space associated with non-open surgery.
Non-open surgeries, such as arthroscopic surgery and laparoscopic surgery, recently have become widely practiced surgical procedures. Such procedures have gained rapid popularity and generally are preferable over the traditional open surgery which requires cutting large incisions through the skin, muscles and membranes to open and expose the body cavity, thereby necessitating longer hospitalization stays and prolonged recovery periods. In non-open surgery, small incisions are made into which tubular conduits, such as cannulae and trocars, are inserted and directed to the site of the operable internal organ or tissue. One or more surgical instruments are introduced through the tubular conduits in order to perform the surgical procedure.
Two fields of non-open surgery are commonly practiced today: shallow surgery, such as arthroscopic surgery, and deep surgery, such as laparoscopic surgery. The arthroscopic procedure typically is performed on body parts located near the skin surface, such as the knee or elbow, for repairing tears of the cartilage or meniscus, shaving irregular, roughened patella and other surfaces, and the like. In arthroscopic surgery, one or more small openings are made in the skin layer as to provide access for an elongated sleeve which is inserted through the surgical opening for receiving surgical instruments.
The laparoscopic procedure generally involves creating small incisions through the navel and through the abdominal wall for viewing and operating on internal areas of the body, such as the uterus, ovaries, gall bladder and appendix. Typically, a trocar tube is introduced through the navel incision for receiving a camera, magnifying lens or other fiber optic device for viewing the surgery. One or more additional trocar tubes are introduced through incisions in the abdominal wall such that laparoscopic surgical tools can be inserted through the tube(s) for manipulating, cutting and/or suturing an internal organ or tissue. In this manner, while viewing a video monitor via the fiber optic device positioned in the navel trocar, the surgeon can grasp an organ or tissue with one surgical tool and simultaneously cut or suture with another surgical device.
The evolution of non-open surgery has given rise to the need of single-shaft surgical instruments which can be inserted through a trocar and easily manipulated by a surgeon. These instruments are fashioned such that they can be inserted lengthwise through the trocar and comprise hand-held controls on the proximal end thereof to operate the distal, tissue-manipulating end of said instrument. Single shaft devices must have a sufficiently small diameter so that they can be inserted into a trocar tube and guided to the operative tissue site. Typically, such instruments are designed to perform one function, such as grasping and stabilizing tissue, cutting tissue, holding a suturing needle or pulling a suturing needle through tissue. A major drawback to non-open surgery is that it requires exceptional motor coordination to grasp and stabilize an organ or tissue with one surgical tool and performing a cutting or suturing procedure on said organ or tissue with a second surgical device, all while viewing a two dimensional video monitor. This disadvantage is particularly acute in performing a laparoscopic suturing procedure.
In laparoscopic suturing, thick tissue, such as uterine tissue, is oftentimes encountered. Consequently, the suturing needle must be of a length sufficient to pass through the tissue being sutured. Typically, the length of these needles is greater than the diameter of the single shaft suturing instruments. As a result, the suturing needle must be inserted lengthwise through a trocar. In the conventional laparoscopic suturing procedure typically practiced today, a straight Semm needle holder having opposing jaws at one end is used in the suturing procedure. This type of needle holder essentially is a clamping device which holds the suturing needle lengthwise between opposing jaws such that it can be introduced through a trocar and guided to the incision site. The tissue to be sutured is grasped by a clamping device which has been previously introduced through a second trocar to the incision site. The suturing needle is repositioned so that the needle is held transversely between the opposed jaws of the conventional needle holder and thereafter is pushed into the first layer of tissue. Oftentimes, the needle does not pass completely through the first layer of tissue and difficulty is encountered in finding the needle in the tissue mass. Once the needle is located, the needle has to be regrasped by the conventional needle holder and pulled through the layer of tissue. The needle again is released, repositioned and regrasped by the needle holder such that it is ready to be passed through the second layer of tissue. An additional problem often encountered with the use of the conventional needle holder is that the needle can slip out of the needle holder if it is not grasped properly or if the tissue is thick.
Accordingly, prior art needle holders for use in laparoscopic surgery have provided the surgeon with inadequate control over both the needle and the tissue to be sutured. The conventional clamping-type devices, described above and in use today, require the needle to be positively grasped between opposed jaws, which can result in slipping, mispositioning, or even premature release of the needle from the jaws during suturing manipulations. Consequently, because of the difficulties encountered in learning and practicing laparoscopic suturing techniques, many surgeons practicing laparoscopic surgery have opted to use single shaft stapling devices as a substitute for conventional suturing. These stapling devices are very expensive to use and significantly increase the cost of laparoscopic surgery.
Other single shaft devices are in use today specifically fashioned for holding a needle, thereby providing adequate needle control. However, since these instruments do not offer means to grasp and stabilize the tissue, which is slippery by nature, the tissue tends to evade needle carrier manipulation or must be grasped by a second instrument. As a result, the surgeon encounters difficulty in controlling and positioning both the needle and the tissue simultaneously, and the patient can suffer complications such as frayed tissue, errant punctures, inadequate stitches, extended surgical duration, hemorrhaging, and the like.
U.S. Pat. No. 4,493,323 to Albright et al. and U.S. Pat. No. 4,621,640 to Mulhollan et al. are representative of prior art suturing instruments for internal suturing without requiring open surgery and are particularly designed for use in arthroscopic surgery, specifically knee surgery. However, such suturing devices require the needle to be continuously manipulated as it progresses through the tissue layer being sutured. Albright et al. provides a device comprising a pair of needles which are forced outwardly through the end of an elongated tube by a plunger in order to penetrate and extend through the tissue to be sutured, the pair of needles then are forced outwardly through the skin layer of the patient so that they can be grasped by the surgeon, and are pulled to position a suture thread loop attached to the needles. For obvious reasons, such a device cannot be used in laparoscopic surgery. Mulhollan et al. discloses a mechanical needle carrier for carrying, gripping and manipulating a suturing needle within the body, particularly a knee joint. The Mulhollan device is inserted through a cannula or tube wherein the needle is guided to the knee tissue. The needle carrying device is positioned such that the needle end can puncture the tissue and the needle thereafter is released from the carrying device. The entire instrument must be withdrawn from the cannula in order to allow insertion of another instrument which pulls the needle through the conduit so that the suture can be tied and set. Although Mulhollan renders better manipulative control over the surgical needle, it is incapable of providing control over the tissue in concert with the needle.
Other suturing devices are known in the arthroscopic surgical art which address the problems of needle control and tissue control by permanently mounting a needle on one of two opposed jaws, thus eliminating the surgeons need to positively grasp and hold the needle by clamping means. These instruments are designed such that the opposed jaws grasp the tissue to be sutured, thereby providing positioning and control of the tissue as the needle punctures the tissue. Such a device is exemplified by U.S. Pat. No. 4,957,498 to Caspari et al. Caspari discloses a suturing instrument for use in arthroscopic surgery comprising a tubular shaft having a jaw assembly at the distal end thereof. A short, curved, hollow needle is affixed to the lower jaw. A suturing thread, originating from a spool mechanism positioned at the proximal end of the tubular shaft, is passed through said shaft and extends longitudinally through the hollow needle. In operation, the instrument drives the needle through the tissue to be sutured while clamping the tissue between the upper and lower jaws. However, the Caspari device does not provide a means of releasing the needle from the needle-holding device after its passage through the tissue. As a result, the surgeon is restricted to a double-pass type of stitch: upon closing of the jaws and the resultant tissue puncture, the suture is passed through the hollow needle, hooked by the jaw opposing the needle-holding jaw, and then pulled back through the hole made by its first pass through the tissue.
Related disadvantages with the Caspari device include the fact the needle is integral with the needle holding device and must be a hollow needle. Moreover, the Caspari needle holder more easily lends itself to breakage due to its intricate design and many parts. Further, the device more readily can become clogged with blood and debris, thereby rendering it ineffective, and is difficult to clean and maintain. Additionally, the Caspari instrument is not suitable for and cannot be adapted for use in a laparoscopic procedure where thick layers of tissue require suturing for several reasons. First, the permanently affixed hollow needle is of insufficient length and as such cannot pass through the thick tissue encountered in laparoscopic surgery. Second, the design of the Caspari device would not allow substitution of a longer suturing needle suitable for laparoscopic surgery because such a needle would prevent the jaw assembly from closing, thereby prohibiting the introduction of the instrument into a laparoscopic trocar.
There still exists a need for a suturing instrument, capable of being introduced through a cannula, trocar or similar conduit to the incision site, which provides superior control over both the suturing needle and the tissue to be sutured. Such a device should provide means whereby a surgeon is afforded with the flexibility of choosing different types of surgical needles, rather than restricting the surgeon to a specific, built-in needle. The device should further provide means for grasping, stabilizing and controlling the tissue being sutured. Additionally, the suturing device should be capable of securably retaining a surgical device whereby the surgeon is not required to positively grasp the needle (thereby risking loss of needle control) and the device also should be capable of releasing the surgical needle once the needle has pierced the tissue layer. Finally, the suturing device should be of a design which is easy to use, inexpensive to manufacture and lends itself to easy cleaning and maintenance.